Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000519459
Ethics application status
Approved
Date submitted
4/10/2007
Date registered
9/10/2007
Date last updated
13/12/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Program to improve memory through exercise for people with dementia
Scientific title
A community-based physical exercise program to reduce functional decline in people with dementia: randomised controlled trial.
Universal Trial Number (UTN)
Trial acronym
PRIME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 2428 0
Condition category
Condition code
Neurological 2530 2530 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four month home exercise program to be completed at least 3 times per week. The program comprises 10 simple exercises to be undertaken under the supervision of a carer.
Intervention code [1] 2147 0
Treatment: Other
Comparator / control treatment
Standard treatment - usual care and clinical management through the hospital's Memory Disorders Outpatient Clinic. This involves consultations with a physician regarding assessment, diagnosis, management and treatment as required and referrals to support services where necessary.
Control group
Active

Outcomes
Primary outcome [1] 3429 0
Cognitive function (Alzheimer's Disease Assessment Scale - cognitive subscale and Mini Mental State Examination).
Timepoint [1] 3429 0
Baseline and 4 months
Secondary outcome [1] 5694 0
Functional fitness (timed up and go, 10 metre walk, functional reach, sit to stand)
Timepoint [1] 5694 0
Baseline and 4 months
Secondary outcome [2] 5695 0
Other functioning (Barthels Activities of Daily Living, Geriatric depression scale, Pittsburgh sleep quality index, Neuropsychiatric Inventory, Clinician's Interview-Based Impression of Change-Plus)
Timepoint [2] 5695 0
Baseline and 4 months
Secondary outcome [3] 5696 0
Carer well-being (Zarit caregiver burden scale, SF-36: Short Form Health Survey 36)
Timepoint [3] 5696 0
Baseline and 4 months
Secondary outcome [4] 5697 0
Plasma levels (glucose, insulin, lipds, testosterone, sensitive C-reactive protein)
Timepoint [4] 5697 0
Baseline and 4 months

Eligibility
Key inclusion criteria
Diagnosed with dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition;
Living with a carer in the community; and
Patient and carer willing and able to participate in daily exercise.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any physical condition that could preclude full participation, such as non-controlled systemic illness, severe physical disability.
Evidence of any neurodegenerative disorders other than dementia;
Commenced dementia medications in the last 3 months;
Already participating in resistance training or aerobic exercise more than once a week.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation following recruitment using sequentially numbered sealed opaque envelopes held by a person independent of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 450 0
7250

Funding & Sponsors
Funding source category [1] 2678 0
Charities/Societies/Foundations
Name [1] 2678 0
Clifford Craig Medical Research Trust
Country [1] 2678 0
Australia
Funding source category [2] 2882 0
Government body
Name [2] 2882 0
Tasmanian Community Fund
Country [2] 2882 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
PO Box 1963
Launceston TAS 7250
Country
Australia
Secondary sponsor category [1] 2419 0
University
Name [1] 2419 0
School of Human Life Sciences, University of Tasmania
Address [1] 2419 0
Locked Bag 1320
Launceston Tasmania 7250
Country [1] 2419 0
Australia
Other collaborator category [1] 66 0
University
Name [1] 66 0
School of Human Life Sciences, University of Tasmania
Address [1] 66 0
Locked Bag 1320
Launceston Tasmania 7250
Country [1] 66 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4597 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 4597 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart TAS 7001
Ethics committee country [1] 4597 0
Australia
Date submitted for ethics approval [1] 4597 0
Approval date [1] 4597 0
06/06/2007
Ethics approval number [1] 4597 0
H0009310

Summary
Brief summary
The objective of the study is to assess the effectiveness of a community-based exercise program for people with dementia in reducing functional decline in the areas of cognitive, physical and behavioural functioning.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28091 0
Address 28091 0
Country 28091 0
Phone 28091 0
Fax 28091 0
Email 28091 0
Contact person for public queries
Name 11248 0
Dr Anthea Vreugdenhil
Address 11248 0
Dementia Research Centre
Launceston General Hospital
PO Box 1963
Launceston TAS 7250
Country 11248 0
Australia
Phone 11248 0
03 63487579
Fax 11248 0
Email 11248 0
[email protected]
Contact person for scientific queries
Name 2176 0
Dr Anthea Vreugdenhil
Address 2176 0
Dementia Research Centre
Launceston General Hospital
PO Box 1963
Launceston TAS 7250
Country 2176 0
Australia
Phone 2176 0
03 63487579
Fax 2176 0
Email 2176 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.